Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

Context

• 95% micro/SME*

• 70% of clinical decisions based on a result from an IVD*

• 40% of global medtech sales (€115b /€45b)*

• 10% UK Field Safety Notices

*BIVDA and Medtech Europe

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The Organisation for Professionals in Regulatory Affairs

19

IVDR implementation roadmap/ heatmap

Consider the implications for your business

Will the IVDR apply?

Inform your senior managers

PreAssessment

Review technical documentation (including labelling and clinical evidence)

What will the IVDR intended purpose be?

Is the QMS adequate? When does it expire?

Review existing certificates

Gap Analysis

Review portfolio

Update technical documentation and labelling

Update roles and relationships (MAID and NB)

Update clinical evidence

Update QMS in line with IVDR

Workplan

Implement UDI

Update PMS

Cost/benefit analysis

Project management team

NB submission timetable

Supply chain provisions

Company structure

Implementation

PRRC

Regulatory updates

NB audits (inc unannounced)

Update senior managers

Product liability insurance

Review progress

IVDR training

Continue to review implementation plan

The Organisation for Professionals in Regulatory Affairs

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